Clindamycin Phoaphate Topical Solution, 1%

Product NDC: 68788-7810
11-digit product format: 687887810
Labeler code: 68788
Product ID: 68788-7810_d773f691-8445-4cab-a725-b5c9aa93b27a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Phosphate Topical Solution, 1%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA209914
Marketing category: ANDA
Marketing start: 2020-10-29
Marketing end: 0000-00-00
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 10 mg/mL
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-7810		D	Discontinued by firm		2026-08-03
excluded package	package	68788-7810	68788-7810-6	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209914-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		2019-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209914-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209914-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2019-01-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209914-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209914-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209914-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209914-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209914-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209914-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209914-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209914-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209914-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209914-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209914-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209914-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209914-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209914-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209914-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209914-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209914-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209914-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209914-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209914-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209914-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209914-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209914-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209914-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209914-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209914-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209914-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209914-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209914-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209914-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209914-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209914-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209914-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209914-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209914-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209914-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209914-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209914-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209914-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209914-001	AT	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7810	CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION, 1% (CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, 1%) SOLUTION [PREFERRED PHARMACEUTICALS INC.]	5	Legacy NDC	20240330_be786fcb-e590-4aab-8968-124dacb977c6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phoaphate Topical Solution USP, 1%	CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%	Encube Ethicals, Inc.	b2dfb76b-db09-43e7-8366-6791449a4918	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209914 application number: ANDA209914
Clindamycin Phoaphate Topical Solution USP, 1%	CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%	Northstar Rx LLC	407f6d80-7de0-45d9-8ad2-5b95d233b96d	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209914 application number: ANDA209914
Clindamycin Phoaphate Topical USP, 1%	CLINDAMYCIN PHOSPHATE TOPICAL USP, 1%	A-S Medication Solutions	19363055-9ae7-4f0f-979d-93d0ee2c803f	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209914 application number: ANDA209914

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH6D7113I8	CLINDAMYCIN PHOSPHATE	24729-96-2	CLINDAMYCIN PHOSPHATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7810-6	68788781006	1 BOTTLE in 1 CARTON (68788-7810-6) > 60 mL in 1 BOTTLE	1 bottle	2020-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate Topical Solution USP, 1%* For External Use	Preferred Pharmaceuticals Inc.	2024-03-28	HUMAN PRESCRIPTION DRUG LABEL	5